U.S. FDA issues 4 observations to Biocon API facility in Bengaluru

An active pharmaceutical ingredient (API) facility of Biocon in Bengaluru has been issued four observations by the U.S. Food and Drug Administration post an inspection.

“The U.S. FDA conducted a surveillance inspection of our API facility (Site 2) located in Bengaluru from September 23-27. Four observations were cited at the end of the inspection, which the company will be addressing within the stipulated time. The company does not foresee any impact on the business,” Biocon said in a filing on Saturday.